Morbid ObesityNCT01249950
Study on the Appropriateness of Bariatric Surgery in Adolescents
An observational study of Morbid Obesity, run by University Hospital, Toulouse at 1 site in France.
Trial summary
single-center study carried out in order to evaluate in prospective among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity, the potential number of patients eligible for surgery. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- feasibility
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: adolescents
Who may be able to join
- failure of weight loss in an organized care> 6 months
- BMI > à 35 kg/m2 with presence of severe co-morbidities (diabetes, moderate or severe OSAS, intracranial hypertension, severe hepatic steatosis), which can be improved by a significant weight loss and sustainable OR BMI > or = 40 kg/m2 with less severe co-morbidities (hypertension, GERD) and may worsen the health status including reduced quality of life.
- Patients must have completed their growth (bone age > 13 for girls and >15 for boys).
- The teenager and his legal representative must have given their informed consent.
- The subject must be affiliated to a social security scheme
Who cannot join
- syndromic obesities
- tumor-induced obesity
- Patient with severe psychiatric disorders
- Patient with eating disorders
- Patients under judicial protection
- Patient under guardianship or curatorship
- Patient participating in another study
Trial locations and contacts
1 site in 1 country.
About this study
single-center study carried out in order to evaluate in prospective among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity, the potential number of patients eligible for surgery.
Read the detailed description
This is a feasibility study in order to file a subsequent national project as part of a PHRC on bariatric surgery in adolescents.
- Conditions
- Morbid Obesity
- Being tested
- feasibility
- Keywords
- Morbid obesity, teenagers, co-morbidities, bariatric surgery, epidemiology
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
feasibilityOther
feasibility
| Study group | Role | What they receive |
|---|---|---|
| adolescents | adolescents with morbid obesity Receives: Other: feasibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
potential number of patients eligible for surgery
evaluate prospectively the potential number of patients eligible for surgery, among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2011
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Béatrice JOURET, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249950
- Sponsor's protocol ID
- 08 157 02
- Other IDs
- 2008-A01320-55
- Status last verified
- Nov 2013
- First submitted
- 26 Nov 2010
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Appropriateness of Bariatric Surgery in Adolescents
- ClinicalTrials.gov ID
- NCT01249950
- Acronym / sponsor ID
- 08 157 02
- Conditions
- Morbid Obesity
- Keywords
- Morbid obesity, teenagers, co-morbidities, bariatric surgery, epidemiology
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
single-center study carried out in order to evaluate in prospective among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity, the potential number of patients eligible for surgery.
Detailed description
This is a feasibility study in order to file a subsequent national project as part of a PHRC on bariatric surgery in adolescents.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adolescents | – | Other: feasibilityadolescents with morbid obesity |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- adolescents
Key inclusion criteria (5 listed)
- failure of weight loss in an organized care> 6 months
- BMI > à 35 kg/m2 with presence of severe co-morbidities (diabetes, moderate or severe OSAS, intracranial hypertension, severe hepatic steatosis), which can be improved by a significant weight loss and sustainable OR BMI > or = 40 kg/m2 with less severe co-morbidities (hypertension, GERD) and may worsen the health status including reduced quality of life.
- Patients must have completed their growth (bone age > 13 for girls and >15 for boys).
- The teenager and his legal representative must have given their informed consent.
- The subject must be affiliated to a social security scheme
Key exclusion criteria (7 listed)
- syndromic obesities
- tumor-induced obesity
- Patient with severe psychiatric disorders
- Patient with eating disorders
- Patients under judicial protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| feasibilityfeasibility | Other | adolescents |
Primary outcome
potential number of patients eligible for surgery
Time frame: 24 months
evaluate prospectively the potential number of patients eligible for surgery, among patients seen or treated in the pediatric endocrinology unit and multidisciplinary management of obesity.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Béatrice JOURET, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
potential number of patients eligible for surgery (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.